Affiliation: Memorial Sloan-Kettering Cancer Center
- Zumsteg Z, Morse N, Krigsfeld G, Gupta G, Higginson D, Lee N, et al. Taselisib (GDC-0032), a Potent Î²-Sparing Small Molecule Inhibitor of PI3K, Radiosensitizes Head and Neck Squamous Carcinomas Containing Activating PIK3CA Alterations. Clin Cancer Res. 2016;22:2009-19 pubmed publisher..Further, combined GDC-0032 and radiotherapy was more efficacious than either treatment alone inPIK3CA-altered HNSCCin vitroandin vivo This strategy warrants further clinical investigation. ..
- Baselga J, CortÃ©s J, Im S, Clark E, Ross G, Kiermaier A, et al. Biomarker analyses in CLEOPATRA: a phase III, placebo-controlled study of pertuzumab in human epidermal growth factor receptor 2-positive, first-line metastatic breast cancer. J Clin Oncol. 2014;32:3753-61 pubmed publisher..HER2, HER3, and PIK3CA were relevant prognostic factors. ..
- Di Cosimo S, Sathyanarayanan S, Bendell J, Cervantes A, Stein M, BraÃ±a I, et al. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015;21:49-59 pubmed publisher..gov identifier: NCT00730379). ..
- Hyman D, Taylor B, Baselga J. Implementing Genome-Driven Oncology. Cell. 2017;168:584-599 pubmed publisher..We review how contemporary approaches are tackling these challenges and will ultimately serve as an engine for biological discovery and increase our insight into cancer and its treatment. ..
- Juric D, Krop I, Ramanathan R, Wilson T, Ware J, Sanabria Bohorquez S, et al. Phase I Dose-Escalation Study of Taselisib, an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors. Cancer Discov. 2017;7:704-715 pubmed publisher..i>Cancer Discov; 7(7); 704-15. ©2017 AACR.See related commentary by Rodon and Tabernero, p. 666This article is highlighted in the In This Issue feature, p. 653. ..
- Baselga J, Zamagni C, Gomez P, Bermejo B, Nagai S, Melichar B, et al. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017;17:585-594.e4 pubmed publisher..6.4%), and vomiting (3.5% vs. 0.7%). The combination of sorafenib with capecitabine did not improve PFS, OS, or ORR in patients with HER2-negative advanced breast cancer. Rates of Grade 3 toxicities were higher in the sorafenib arm. ..
- Baselga J, Costa F, Gomez H, Hudis C, Rapoport B, Roche H, et al. A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. Trials. 2013;14:228 pubmed publisher..RESILIENCE will provide definitive PFS data for the combination of sorafenib and capecitabine in advanced HER2-negative breast cancer and better characterize the benefit-to-risk profile. Clinicaltrials.gov, NCT01234337. ..
- Baselga J, Gomez P, Greil R, Braga S, Climent M, Wardley A, et al. Randomized phase II study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab with cisplatin versus cisplatin alone in patients with metastatic triple-negative breast cancer. J Clin Oncol. 2013;31:2586-92 pubmed publisher..Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting...
- Juric D, Dienstmann R, Cervantes A, Hidalgo M, Messersmith W, Blumenschein G, et al. Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Clin Cancer Res. 2015;21:2462-70 pubmed publisher..Phase II studies were initiated with flat (nonweight-based) dosing at 1,100 mg q2w in SCCHN and colorectal cancer. ..
- Baselga J, Im S, Iwata H, Cortes J, De Laurentiis M, Jiang Z, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18:904-916 pubmed publisher..No further studies are being pursued because of the toxicity associated with this combination. Novartis Pharmaceuticals Corporation. ..
- Reynolds K, Bedard P, Lee S, Lin C, Tabernero J, Alsina M, et al. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017;17:646 pubmed publisher..LJM716 was well tolerated; the MTD was not reached, and the RDE was 40 mg/kg QW. Further development of LJM716 is ongoing. Clinicaltrials.gov registry number NCT01598077 (registered on 4 May, 2012). ..